drugset / Trial / NCT00091143
Fludarabine Followed by Vaccine Therapy and White Blood Cell Infusions in Treating Patients With Unresectable or Metastatic Melanoma
Phase 1
Completed
20 enrolled
National Cancer Institute (NCI)
National Cancer Institute (NCI) · collab
RandomizedTreatment
Summary
RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Vaccines made from peptides may make the body build an immune response to kill tumor cells. Infusions of a person's white blood cells may be able to replace immune cells that were destroyed by chemotherapy. Combining fludarabine with vaccine therapy and white blood cell infusions may kill more tumor cells. PURPOSE: This randomized phase I trial is studying the side effects of giving vaccine therapy together with fludarabine and white blood cell infusions and to see how well it works in treating patients with unresectable or metastatic melanoma.
Timeline
- Start
- 2004-07
- Primary completion
- 2010-03
- Completion
- 2010-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fludarabine | Small molecule | — | Intravenous |
| Subject | gp100 antigen | Peptide | — | Subcutaneous |
| Background | incomplete Freund's adjuvant | Other / unclassified | — | Subcutaneous |
| Background | keyhole limpet hemocyanin | Vaccine | — | Subcutaneous |